Fetroja (Cefiderocol) in India: What Published Data Say About This Siderophore Cephalosporin

Cefiderocol, sold as Fetroja, is a cephalosporin antibiotic designed to enter Gram-negative bacteria through their own iron-uptake systems. Three recent developments make it worth a fresh look: the Infectious Diseases Society of America (IDSA) published a new edition of its resistant Gram-negative guidance on 30 July 2026; the US prescribing information for Fetroja was revised in July 2026; and the Indian Council of Medical Research (ICMR) continues to report rising carbapenem resistance in Indian tertiary-care hospitals. This article summarises what those sources and the pivotal trials state, for hospital pharmacists, microbiology and infection-control teams, and procurement departments.

A.K. Pharma, a medicine distributor in Delhi and pharmaceutical distributor in Delhi, supplies imported hospital medicines to healthcare institutions across India. We are not clinicians, and we do not advise on which patients should receive any antibiotic. What follows is reporting on published evidence, with the original sources linked throughout.

1. Why Cefiderocol Is Back in the Resistance Conversation

Antibiotic resistance among Gram-negative bacteria is a recurring theme in Indian hospitals, and several sources published or updated in 2026 bear directly on how cefiderocol is discussed. The table below places them in sequence, with older background items included for context.

1.1 Timeline of the Key Developments

Date	Event	Source
Nov 2019	US FDA approves Fetroja for complicated urinary tract infections (cUTI)	BioSpace
Sep 2020	US FDA approves Fetroja for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)	BioSpace
2020	European Medicines Agency approval, as stated by GARDP	GARDP
Oct 2020	APEKS-NP and CREDIBLE-CR trial results published in The Lancet Infectious Diseases	CIDRAP / Lancet ID
May 2024	WHO Bacterial Priority Pathogens List 2024 keeps carbapenem-resistant Acinetobacter baumannii and carbapenem-resistant Enterobacterales in the critical priority group	WHO
2024 data year	ICMR AMRSN 8th annual report covers 99,027 culture-positive isolates from tertiary-care hospitals	ICMR
Jul 2026	US prescribing information for Fetroja revised (7/2026)	FDA label
30 Jul 2026	IDSA 2026 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections published	IDSA
29 Sep 2026	Merck announces it will stop manufacturing and marketing the antibiotic Recarbrio in the US, a decision the company said was not related to safety or quality	CIDRAP

Framing note: the trials and approvals above are background; the IDSA 2026 guidance and the July 2026 label revision are the recent updates. Dates are as reported by the cited sources.

The Recarbrio announcement is relevant here for a different reason: it is a reminder, reported by CIDRAP, that availability of newer antibiotics can change with commercial decisions, which is why many hospital procurement teams track the supply status of reserve-group antibiotics closely.

2. What Cefiderocol Is and How It Is Described to Work

2.1 The Siderophore Mechanism

According to GARDP, cefiderocol is a siderophore cephalosporin that enters bacterial cells by passive diffusion through porin channels and also binds iron and is actively transported into the cell through bacterial iron transporters. CIDRAP’s summary of the pivotal trials adds that the drug can overcome other resistance mechanisms, such as efflux pumps, that bacteria use to evade antibiotics. Once inside, cefiderocol acts as a cephalosporin, targeting bacterial cell-wall synthesis.

2.2 In-Vitro Activity Statements in the IDSA 2026 Guidance

The IDSA 2026 guidance summarises surveillance data on how often isolates test susceptible to cefiderocol. Selected statements from its rationale sections are below; these describe laboratory susceptibility, not clinical outcomes.

Pathogen group	Statement in the IDSA 2026 guidance
KPC-producing Enterobacterales	Cefiderocol shows greater than 95% in-vitro activity against isolates
OXA-48-like-producing Enterobacterales	Cefiderocol is active against over 95% of isolates
Carbapenem-resistant A. baumannii (CRAB)	More than 90% of isolates susceptible in vitro; only about 60% of NDM-producing CRAB isolates remain susceptible
Stenotrophomonas maltophilia	Susceptibility approaches 100%, including among isolates resistant to other commonly used agents

2.3 Limitations the Guidance Itself Mentions

• Cefiderocol has no companion beta-lactamase inhibitor; the guidance notes a theoretical concern about effectiveness when beta-lactamase expression is very high.
• Emergence of resistance during therapy in CRAB is described as a concern, most often linked to changes in iron-uptake pathways and beta-lactamase overexpression.
• In S. maltophilia, the guidance notes that the supporting evidence is largely from susceptibility data and neutropenic animal models rather than clinical outcome studies.

3. What the Current FDA Label States

The US prescribing information (revised 7/2026) is the most recent regulator-approved text for Fetroja that we reviewed. It is a US document and is not the Indian prescribing information; Indian users should refer to the approved Indian labelling supplied with the product.

3.1 Indications as Worded in the Label

Indication (adults aged 18+)	Organisms named in the label
Complicated urinary tract infections, including pyelonephritis	Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae complex
Hospital-acquired and ventilator-associated bacterial pneumonia	Acinetobacter baumannii complex, E. coli, Enterobacter cloacae complex, K. pneumoniae, P. aeruginosa, Serratia marcescens

The label organises its indications by infection site and by susceptible organisms. Carbapenem resistance is not itself named as a stand-alone indication in the US label. The label also states that safety and effectiveness in patients younger than 18 years have not been established.

3.2 The Usage Statement

The label states that Fetroja should be used only for infections proven or strongly suspected to be caused by susceptible bacteria, that culture and susceptibility information should be considered when available, and that in its absence local epidemiology and susceptibility patterns may contribute to empiric selection.

3.3 Administration

The label describes intravenous administration as a 3-hour infusion, with dose adjustments specified for renal function, including intermittent haemodialysis, continuous renal replacement therapy and creatinine clearance of 120 mL/min or greater. Dosing is a matter for the prescriber and the approved prescribing information; this article does not reproduce dosing tables.

4. The Pivotal Trial Data

Three phase 3 trials sit behind the regulatory record. According to CIDRAP, the two published in The Lancet Infectious Diseases in October 2020 were both designed and funded by Shionogi.

4.1 APEKS-cUTI (Label “Trial 1”)

The label describes 448 hospitalised adults randomised 2:1 to cefiderocol or imipenem/cilastatin for 7 to 14 days. In the microbiological intent-to-treat population (371 patients), the composite of microbiological eradication and clinical cure at test of cure was 183/252 (72.6%) with cefiderocol versus 65/119 (54.6%) with imipenem/cilastatin (treatment difference 18.6; 95% CI 8.2 to 28.9). Clinical response alone was similar: 89.7% versus 87.4%.

4.2 APEKS-NP (Label “Trial 2”)

In APEKS-NP, 298 hospitalised adults with HABP/VABP received cefiderocol or high-dose, extended-infusion meropenem, with linezolid added in both arms for Gram-positive coverage. Per the label, day-14 all-cause mortality was 18/145 (12.4%) with cefiderocol versus 18/147 (12.2%) with meropenem (difference 0.2; 95% CI -7.2 to 7.7), meeting the non-inferiority endpoint. Day-28 mortality was 22.1% versus 21.1%, and clinical cure at test of cure was 64.8% versus 66.7%. The label notes that about 4% of patients were from the United States and 67% from Europe. The published analysis, as reported by CIDRAP, gave day-14 mortality as 12.4% versus 11.6%.

The label also reports a subgroup of 51 patients with A. baumannii complex at baseline: day-14 mortality was 5/26 (19.2%) with cefiderocol versus 4/25 (16.0%) with meropenem, and day-28 mortality was 9/26 (34.6%) versus 6/25 (24.0%). These are small numbers and should be read as descriptive.

4.3 CREDIBLE-CR

CREDIBLE-CR enrolled adults with serious carbapenem-resistant Gram-negative infections in 95 hospitals across 16 countries. As summarised by CIDRAP, 150 patients were treated (101 with cefiderocol, 49 with best available therapy, mostly colistin-based combinations). Reported outcomes were:

• Nosocomial pneumonia: clinical cure 20/40 (50%) with cefiderocol versus 10/19 (53%) with best available therapy.
• Bloodstream infection or sepsis: clinical cure 10/23 (43%) versus 6/14 (43%).
• Complicated UTI: microbiological eradication 9/17 (53%) versus 1/5 (20%); these are very small numbers.

4.4 Summary Table

Trial	Comparator	Population	Headline reported result
APEKS-cUTI	Imipenem/cilastatin	448 randomised adults, cUTI	Composite response 72.6% vs 54.6%
APEKS-NP	Meropenem (extended infusion)	298 treated adults, HABP/VABP	Day-14 mortality 12.4% vs 12.2% (non-inferior)
CREDIBLE-CR	Best available therapy	150 treated adults, carbapenem-resistant infections	Clinical cure similar; higher all-cause mortality in the cefiderocol arm

5. The Mortality Signal and How It Has Been Reported

CREDIBLE-CR is also the source of a warning in the label. This section reports what the label, the trial coverage and the IDSA guidance say about it.

5.1 What the Label States

Section 5.1 of the label, “Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections”, reports that 28-day all-cause mortality was 25/101 (24.8%) with cefiderocol versus 9/49 (18.4%) with best available therapy (difference 6.4%; 95% CI -8.6 to 19.2), and that mortality remained higher through day 49: 34/101 (33.7%) versus 10/49 (20.4%) (difference 13.3%; 95% CI -2.5 to 26.9). The label states that deaths were generally in patients with infections caused by non-fermenters such as A. baumannii complex, S. maltophilia and P. aeruginosa, and that the cause of the increase has not been established. The confidence intervals are wide and include no difference.

5.2 How the Trial Coverage Described It

CIDRAP reported that the mortality difference appeared to be largely driven by Acinetobacter infections in patients with pneumonia or bloodstream infection or sepsis, that the cefiderocol-treated Acinetobacter patients had more baseline risk factors (renal dysfunction, ICU treatment, septic shock), and that no mortality difference was found in patients without Acinetobacter. An accompanying Lancet Infectious Diseases commentary, as summarised by CIDRAP, said the trials suggest cefiderocol performs about as well as comparators it described as suboptimal for these infections, and that use in carbapenem-resistant Acinetobacter infections should be limited.

5.3 What the IDSA 2026 Guidance Reports on CRAB

The IDSA guidance reviews the CRAB data in more detail. It reports, for the CREDIBLE-CR CRAB subgroup (54 patients), 28-day survival of 51% (20/39) with cefiderocol versus 82% (14/17) with alternative regimens; in a second randomised trial of 47 patients with CRAB pneumonia, 14-day survival of 78% (18/23) versus 83% (20/24) with high-dose extended-infusion meropenem; and in a third trial of 25 patients with CRAB bacteraemia, 30-day survival of 55% (6/11) versus 50% (7/14). It also cites two meta-analyses of mostly observational studies showing higher pooled 30-day survival with cefiderocol-based regimens (58% versus 40%, and 62% versus 37%), while noting heterogeneity and that no comparator patients in those observational studies received sulbactam-durlobactam. The guidance describes clinical outcome data for cefiderocol in CRAB as inconclusive.

6. What the IDSA 2026 Guidance Says About Cefiderocol, by Pathogen

The IDSA 2026 Guidance was written by a panel of six infectious diseases specialists and replaces the 2024 version. It states that it focuses on clinical practice in the United States and that antimicrobial-resistance epidemiology and antibiotic availability vary geographically. The table summarises where cefiderocol appears; it does not reproduce the guidance’s full reasoning, and readers should consult the document itself.

6.1 Cefiderocol’s Position in the Guidance

Pathogen / infection	How the guidance positions cefiderocol	Other agents named
NDM-producing Enterobacterales (invasive)	One of two preferred options, with aztreonam-avibactam	Ceftazidime-avibactam plus aztreonam named as an alternative
KPC-producing Enterobacterales (invasive)	Alternative option	Preferred: ceftazidime-avibactam, imipenem-relebactam, meropenem-vaborbactam
OXA-48-like-producing Enterobacterales (invasive)	Alternative option	Preferred: ceftazidime-avibactam
DTR P. aeruginosa, complicated UTI	Listed among preferred options (alphabetical, no order of preference); guidance notes consideration of reserving it for NDM-producing and non-fermenting organisms	Ceftazidime-avibactam, ceftolozane-tazobactam, imipenem-relebactam
Invasive CRAB	Alternative option, in combination with at least one other agent	Preferred: sulbactam-durlobactam plus a carbapenem
Invasive S. maltophilia	Preferred as monotherapy, with the guidance acknowledging this rests largely on animal and susceptibility data	Aztreonam-avibactam (preferably with a second agent) as an alternative

6.2 Reserving Newer Agents

For infections caused by ESBL-producing and AmpC-producing Enterobacterales, the guidance states that newer agents, including cefiderocol, are expected to be active but are preferentially reserved for carbapenem-resistant organisms. The 2026 update also lists data from the GAME CHANGER trial among its additions; readers can find those details in the guidance itself.

7. The Indian Resistance Context: ICMR Surveillance Data

The ICMR Antimicrobial Resistance Research and Surveillance Network (AMRSN) annual report for 2024 is the 8th edition and covers 99,027 culture-positive isolates. ICMR states that the network collects data from tertiary-care hospitals and that the findings are not reflective of community-level resistance and should not be extrapolated to community settings.

7.1 Selected Findings Reported for 2024

Organism / marker	Finding reported by ICMR
Klebsiella pneumoniae	Meropenem susceptibility fell from 48.1% (2017) to 35.1% (2024); imipenem from 58.5% to 31.2%
Escherichia coli	Meropenem susceptibility fell from 73.2% (2017) to 62.9% (2024); imipenem from 81.4% to 57.6%
Pseudomonas aeruginosa	Imipenem resistance rose from 26% (2017) to 43% (2024); meropenem resistance from 31.3% to 38%; carbapenem resistance driven predominantly by metallo-beta-lactamase genes, particularly NDM and VIM
Acinetobacter baumannii	Meropenem resistance 91.0% in 2024; blaOXA-23 the predominant carbapenemase, with rapidly expanding NDM integration, often in co-carriage
Carbapenemase genes	OXA-48 detected in 25.57% of K. pneumoniae isolates and NDM-1 in 14.47% of E. coli isolates in the gene profiling described
Healthcare-associated infections	Gram-negative bacteria accounted for 72.1% of healthcare-associated bloodstream infections; A. baumannii, K. pneumoniae and P. aeruginosa made up nearly 80% of ventilator-associated pneumonia pathogens

7.2 What the ICMR Report Says About Cefiderocol

In its clinical-relevance commentary, the ICMR report states that cefiderocol may be considered against metallo-beta-lactamase-producing P. aeruginosa if in-vitro susceptibility is confirmed, and that cefiderocol, if available and susceptible in vitro, can be used against both OXA- and NDM-producing A. baumannii. The same report notes that sulbactam-durlobactam, the agent the IDSA guidance lists as preferred for invasive CRAB, was not yet available in India at the time of writing. As with the IDSA text, these are statements attributed to the source; treatment choices are for treating physicians and local antimicrobial stewardship committees.

8. Global Access and Where India Fits

GARDP, the Global Antibiotic Research and Development Partnership, describes a licence and technology-transfer agreement with Shionogi and the Clinton Health Access Initiative (CHAI) signed in 2022, giving GARDP rights to manufacture and commercialise cefiderocol through sub-licensees in 135 countries that normally face delayed access to newer antibiotics. GARDP states that it signed a manufacturing sub-licence with India-based Orchid Pharma in 2023, that Orchid synthesised the active ingredient at laboratory scale in 2024, and that construction of dedicated manufacturing facilities in Chennai is ongoing for 2025 to 2027, with supply pending local authorisation or national regulatory approval.

8.1 What This Means for Imported Supply Today

Until any locally manufactured product is authorised, hospitals that need Fetroja obtain it as an imported medicine through licensed channels. Our explainers on why some medicines are imported instead of manufactured in India, the difference between a Named Patient Program and a Patient Assistance Program, and the real cost of sourcing imported medicines from the wrong distributor cover the procurement side. Anyone verifying the regulatory status of an imported product can consult the CDSCO website.

8.2 Reference Points

• GARDP states that cefiderocol has been added to the WHO Model List of Essential Medicines.
• The WHO Bacterial Priority Pathogens List 2024 places carbapenem-resistant A. baumannii and carbapenem-resistant Enterobacterales in the critical priority group and carbapenem-resistant P. aeruginosa in the high priority group.
• The manufacturer of Fetroja is Shionogi & Co., Ltd..

9. Safety Information as Stated in the Label

The following is drawn from the US label and is provided for awareness, not as a substitute for the approved prescribing information.

9.1 Adverse Reactions Reported in the Trials

Trial setting	Adverse reactions reported (cefiderocol arm)
cUTI (n=300)	Diarrhoea 4%, infusion-site reactions 4%, constipation 3%, rash 3%; candidiasis, cough, elevated liver tests, headache, hypokalaemia, nausea each 2%
HABP/VABP (n=148)	Elevated liver tests 16%, hypokalaemia 11%, diarrhoea 9%, hypomagnesaemia 5%, atrial fibrillation 5%

9.2 Warnings and Precautions Listed

• Increase in all-cause mortality in carbapenem-resistant infections in CREDIBLE-CR (see Section 5).
• Hypersensitivity: serious and occasionally fatal reactions have been reported with beta-lactams; cross-hypersensitivity may occur in patients with penicillin allergy.
• Clostridioides difficile-associated diarrhoea: reported with nearly all systemic antibacterial agents, including Fetroja.
• Seizures and other CNS reactions: reported with cephalosporins, particularly with renal impairment or when recommended dosages are exceeded.
• Drug-resistant bacteria: use without a proven or strongly suspected bacterial infection is described as unlikely to benefit patients and as increasing the risk of resistance.

9.3 Other Label Statements

• Cefiderocol may cause false-positive dipstick results for urine protein, ketones or occult blood; the label states that alternate laboratory methods should be used to confirm positive tests.
• There are no available data on Fetroja use in pregnant women, according to the label.

10. Storage and Handling for Hospital Pharmacies

10.1 Storage Conditions Stated in the Label

Section 16.2 of the label states that Fetroja vials should be stored refrigerated at 2°C to 8°C, protected from light and kept in the carton until use. Fetroja is supplied as a lyophilised powder in 1 gram single-dose vials.

10.2 After Reconstitution

• The label states that a reconstituted vial can be held for up to 1 hour at room temperature, and that the solution should be transferred and diluted into the infusion bag immediately.
• The diluted infusion solution is stated to be stable for up to 6 hours at room temperature, or up to 24 hours refrigerated at 2°C to 8°C protected from light, with the infusion then completed within 6 hours at room temperature.
• Unused reconstituted solution is to be discarded, per the label.

A.K. Pharma stores and dispatches medicines under manufacturer-labelled conditions. Hospital pharmacies should rely on the approved labelling accompanying each pack for storage and preparation requirements.

11. Sourcing Fetroja in India

Fetroja is a prescription-only medicine. It is procured by hospitals, ICUs and pharmacies against valid prescriptions through licensed distributors.

11.1 What A.K. Pharma Provides, and What It Does Not

• Provides: genuine, manufacturer-sourced stock; storage and dispatch under labelled conditions; GST invoicing and batch records; institutional supply; pan-India delivery. See how we ensure genuine medicine supply across India.
• Does not provide: medical advice, patient selection, prescribing guidance, susceptibility-testing interpretation or dosing instructions. A.K. Pharma is a distributor, not a healthcare provider.
• Access programmes: information on our Patient Assistance Program is available on our site.

To check availability on the Fetroja product page or request a quote, contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827.

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• Browse all anti-infective medicines at A.K. Pharma
• Browse the full product range, read more on our blog or learn about A.K. Pharma

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